Local clinical trial approval times in the UK

Aim: This study aimed to evaluate the impact of local approval times on the schedule of a large multicentre study in the UK. Method: We reviewed the approval times of 178 applications that were made to the UK National Health Services Trusts (across 159 hospitals and 19 primary care trusts). Results: The mean time for approval was 82 days; more than half the submissions (94; 53%) took longer than 60 days for a decision. The reason for taking over 60 days varied but review of the trial documentation revealed that delays occurred in the Hospital R&D Office for 25 (14%) submissions, at the hospital or primary care trust level for 14 (8%) submissions, while the investigator was responsible for 23 (13%) applications taking longer than 60 days. Conclusion: Local submissions are a source of delayed start up in many centres participating in clinical trials; however, reasons for delay are not consistent across the applications and cannot be attributed to one specific part of the local approval process. © 2006 Adis Data Information BV. All rights reserved.